Medical tubing and catheter control

ABSTRACT

One embodiment is an improved method for providing a tube for attachment to a medical device such as a catheter that provides for intermittent changes in tube path length as a result of body movement thereby reducing the stress and pain caused by pulling on the device, as well as the optional provision to provide a very low, controlled tension that provides improved stability of the medical device without damage to the surrounding body tissues. In at least one embodiment, there is a decrease in infection risk by the patient. This controlled tension can be applied or removed intermittently by a medical practitioner or the patient. Other embodiments provide for extension in tubal path length while simultaneously providing for intermittent or continuous low tension pull on the catheter. Provision is also made for a continuous smooth fluid path with no moving internal parts.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. provisional patentapplication No. 61/359,912 filed Jun. 30, 2010 and U.S. provisionalpatent application No. 61/478,566 filed Apr. 25, 2011

FEDERALLY SPONSORED RESEARCH

NONE

SEQUENCE LISTING

Not Applicable

BACKGROUND

1. Field of Invention

This invention relates to fluid handling lines and their attachment tocatheters or other medical devices, more specifically to tube lengthcompensation features that help to stabilize and isolate the catheter orother medical devices.

2. Prior Art

There are many areas in the medical field where a fluid handling tube isattached to a device fastened onto or into the body. Problems arise thatare the result of body movements that alter the length of the tubalpath, instances where the tube is subjected to sudden hard tugs, andmovement of the device itself as a result of skin movement even whenfastened down with adhesive tape. In cases where the device is acatheter, whether urinary, IV, or other, the movement caused and theforces exerted may cause damage to the organ or vein as well as actualdislodgement of the catheter

In the case of urinary catheters, which are flexible tubes, usually madeof Latex or a Latex blend, that are passed through the urethra and intothe bladder. The catheter is retained inside the bladder by means of aballoon, located at the inserted end, which is inflated with sterilewater. The diameter of the inflated balloon is greater than the internaldiameter of the urethra. The external end of the catheter is attached toa drainage tube which leads to a drainage (or collection) bag. Thedrainage tube is usually secured to the leg of the patient in order tohelp control wild swings in the tubing and the resultant effects on thecatheter. Care must be taken, when securing the drainage tube to theleg, to ensure a sufficient length of tubing is available to form aloop. If not enough slack tubing is available, the patient risksdamaging their bladder if they stretch their leg too far. Thisconfiguration, however, creates another problem. The inflated balloonprevents the catheter from accidentally being pulled out of the bladder,but there is nothing restricting the catheter from moving further intothe bladder. Because of the extra length of tubing loop between theconnection point on the leg and the catheter balloon, the catheterballoon is free to move within the bladder, and will move every time thepatient's leg moves. This movement causes both discomfort and irritationand, as a result, an increased risk of infection. When the cathetermoves in far enough, the top of the catheter will bump against thebladder top. This is thought by many to be a cause for bladder spasms, avery painful condition. As the catheter moves back down, such as whenthe leg is stretched sideways, the tubing will pull out the catheteruntil the balloon rests on the bottom of the bladder. The pulling in andpushing out, or pistoning, of the catheter, causes irritation of theurethra, but more significantly, increases the risk of catheterassociated urinary tract infections.

Current state of the art for urinary catheter securement is a device,which can secure the catheter directly to the thigh, but can be shown tobe self defeating. In this case, the catheter itself is fastened to thethigh thus guaranteeing that the catheter will piston in and out withevery leg movement. If placed improperly, severe bladder damage mayresult.

According to the Centers for Disease Control and Prevention (CDC)website, each year, 30,000,000 urinary catheters are inserted into over5 million patients in acute care hospitals and extended care facilitiesin the U.S. alone. Up to 25% of these patients, over one million peryear, develop catheter associated urinary tract infection (CAUTI), whenrequiring catheterization for at least 7 days; the daily risk is 5%.CAUTI is the most common nosocomial infection, and the second mostcommon cause of nosocomial blood stream infection. Studies suggest thatpatients who have developed CAUTI have an increased institutional deathrate, unrelated to the development of urosepsis. As the population growsin size and in age, and the average life expectancy rate increases, eachyear more and more people will require catheterization. This along withthe unwillingness, of a growing number of health insurance companies, topay hospitals for nosocomial infection treatment, creates an urgent needfor a solution.

SUMMARY OF THE INVENTION

To effectively reduce the discomfort and risk of infection caused by theuse of a Foley catheter, a controlling device is needed to compensatefor the changes in the length of the drainage tube path, as the distancefrom the catheter to the attachment point on the thigh changes. In thisway, there is no need for a free loop of slack drainage tubing. The freeloop causes an increase in pistoning, as the loop swings and changessize with the patient's movement. The free loop can also get caught onclothing resulting in a substantial pull on the catheter, which candamage the catheter as well as the patient's bladder and/or urethra. Allof these movements further increase the irritation on the penis tip.

To further reduce pistoning, the controlling device described hereincould provide a continuous, but minimal pull (minimal pull is that forcegreat enough to hold the catheter balloon at the bottom of the bladder,but not great enough to cause damage to the blood vessels and tissue onthe bladder bottom if applied continuously, present approximation,subject to actual testing, is less than 3 ounces) on an engaged Foleycatheter such that the balloon of the catheter will always be resting onthe bottom of the bladder. This action, in conjunction with the means ofcompensating for the changes in the length of the drain tube path fromthe catheter to the attachment point on the thigh, will protect thebladder and the urethra from damage caused by a very strong pull on thecatheter, such as occurs when the tubing catches on something or the legmovement causes an excessive pull as well as reducing the pistoningaction in and out of the urethra. The urethra is further protected byreducing the pistoning of the catheter and the associated introductionof foreign matter that adheres to the moist catheter when it exits theurethra, and is re-introduced into the urethra when it re-enters withthe accumulated debris, lint and fecal matter that has adhered to themoist catheter.

Furthermore, the said method is non-invasive and low cost. It couldpotentially save hospitals millions of dollars each year by reducingtime and medication costs associated with the treatment of CAUTI, not tomention the savings of those lives that are already in a weakened stateand could not withstand yet another infection.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a typical male Foley urinary catheter attached to acompensating device (or controller) with a connector. The compensatingdevice is illustrated as being attached with adhesive tape to the thighand the outgoing tube leading to a collection bag.

FIG. 2A shows a front view of the tubing and the catheter controller inaccordance with one embodiment.

FIG. 2B shows an exploded view the tubing and the catheter controller inaccordance with one embodiment.

FIG. 3A shows the tubing and the catheter controller with the calibratedforce acting on the tension spring in accordance with one embodiment.

FIG. 3B shows the tubing and the catheter controller with a forcegreater than the calibrated force, causing the tension spring tolengthen and allowing a greater length of drainage tube.

FIGS. 4A and 4B show an alternative embodiment of the controller.

FIG. 5 shows another alternative embodiment of the controller.

FIG. 6 shows top and bottom views of an adjustment dial in accordancewith one embodiment.

FIG. 7 shows a spring loaded slide with the spring un-compressed andwith the spring compressed in accordance with one embodiment.

FIG. 8 shows a base with a dial mounting post and recesses for the dialand slide in accordance with one embodiment.

FIG. 9A shows a front view of an alternative embodiment with a means foradjusting the tension of the tension spring in the un-tensionedposition.

FIG. 9B shows a cross-section view of one embodiment with a means foradjusting the tension of the tension spring in the minimum-tensionedposition.

FIG. 10A shows a front view of an alternative embodiment with a meansfor adjusting the tension of the tension spring in the tensionedposition.

FIG. 10B shows a cross-section view of one embodiment with a means foradjusting the tension of the tension spring in the tensioned position.

FIG. 11A shows a cross-section view of one embodiment with a means foradjusting the tension of the tension spring and with a cover plate.

FIG. 11B shows a cross-section view of one embodiment with a means foradjusting the tension of the tension spring in the tensioned position.

FIG. 12 shows another embodiment that would allow for compensating tubepath length changes, while also providing a means to keep a lowadjustable tension on the catheter.

FIG. 13 shows another embodiment that utilizes a controlled thin wallelastomer type of tube in a protective shell that provides a smoothcontinuous path for the fluid while allowing for tube lengthcompensation as well as a continuous low tension pull on the catheter.

FIGS. 14A, 14B, and 14C show a device similar to FIG. 13, but with theadded feature of an enclosed telescoping inner shell. This arrangementallows for greater tube length compensation for the same size device aswell as a means to easily remove the constant tension feature withoutprofessional help.

FIGS. 15A and 15B show an embodiment of the same concept as applied toan IV Catheter.

DRAWINGS Reference Numerals

-   -   100—Foley catheter    -   102—attachment tape    -   104—compensating device    -   106—incoming tube    -   108—outgoing (or drainage) tube    -   110—tube connectors    -   112—collection bag    -   200—first embodiment    -   202—base    -   204—tube loop    -   206—connection to external end of catheter    -   208—connection to collection bag    -   210—tension spring (or elastic member)    -   212—cover plate    -   214—attachment of tube to base    -   215—bottom edge of base    -   216—underside surface of base    -   218—tube compartment    -   220—bottom section of base    -   302—calibration markings    -   304—direction of force by tension spring    -   306—direction of tension on Foley catheter    -   400—second embodiment    -   402—cover strap    -   404—adhesive section on cover strap    -   500—third embodiment    -   502—injection molded base    -   504—cover plate    -   506—living hinge    -   508—tube compartment walls    -   510A—snap fitting (male end)    -   510B—snap fitting (female end)    -   512—adhesive release holes/breathability holes    -   600—tension adjustment cam    -   602—recess for mounting post    -   604—attachment point of tension spring    -   606—recess for slide in un-tensioned position    -   608—recess for slide in tensioned position    -   610—dial handle    -   700—slide    -   702—compression spring (non-compressed)    -   702A—compression spring (compressed)    -   704—front of slide    -   706—slide handle    -   800—base for adjustable embodiment    -   802—post for mounting cam    -   804—dial compartment    -   806—slide compartment    -   808—rib for preventing drainage tube/tension spring contact    -   900—adjustable embodiment    -   902—cover for adjustable embodiment    -   904—cutout for dial handle    -   906—cutout for slide handle    -   1210—container    -   1212—tube bottom    -   1214—hole    -   1222—outgoing tube    -   1226—incoming tube    -   1228—bellows type section    -   1230—cap    -   1240—spring    -   1242—threaded section    -   1310—outer shell cover    -   1311—Outer Shell Exiting Cover End    -   1312—incoming tube    -   1313—outgoing tube    -   1314—elastomer tube (or elastic member)    -   1316—D-shaped slider    -   1317—outer shell exiting end hole    -   1319—outer shell incoming cover end    -   1322—stop projection    -   1324—outer shell cover end    -   1410—outer shell    -   1411—outer shell exit end    -   1412—incoming tube    -   1413—outgoing tube    -   1414—elastic tube (or elastic member)    -   1416—slider    -   1417—slider hole    -   1418—safety pin entry hole    -   1424—exiting hole    -   1430—outer shell bottom plate (base)    -   1432—slider stop    -   1434—inner shell stop    -   1440—inner shell    -   1442—inner shell back plate    -   1444—inner shell incoming hole    -   1446—inner shell maximum movement stop    -   1448—inner shell leading edge    -   1449—dotted line (secondary position)    -   1450—safety pin    -   1452—raised projection    -   1512—incoming tube    -   1514—elastic tube    -   1552—IV outer shell    -   1554—IV inner shell    -   1556—IV needle/catheter    -   1560—inner shell stop

DETAILED DESCRIPTION First Embodiment

FIG. 1 shows a typical male Foley urinary catheter 100, inside thebladder with the incoming tube 106 leading to a compensating device 104thru connector 110. The device 104 is attached to the thigh withadhesive tape 102. The outgoing tube 108 leads to the collection bag 112thru a second connector 110.

One embodiment of the controller as an elasticized compensating device,herein called the first embodiment 200 is shown in FIGS. 2A-3B. FIG. 2Ashows a front view of the first embodiment 200. FIG. 2B shows anexploded view of the first embodiment 200. A base 202, designed to housea flexible tube loop 204 and a tension spring (or elastic member) 210,is molded out of a soft foam rubber or plastic and has an adhesive backsurface 216 (FIG. 2B). The tube loop 204 sits in the drainage tubecompartment 218. One end 206 (incoming tube) of the tube loop 204 isconnected to the external end of the Foley catheter 100. The other end208 (outgoing tube) of the tube loop 204 is connected to a drainagecollection bag. A tension spring 210 bends and holds the tube loop 204as seen in FIG. 2A. The tension spring 210 and the side of the drainage(or outgoing) tube 208 are attached to the base 202 in section 214. Thegeometry of section 214, positions the tube loop 204 at an anglerelative to the bottom edge 215 of the base 202 that is appropriatewhether the leg is straight of bent. Shown in FIG. 2B, this embodimentuses a base 202 that is molded with a curve to fit the contour of theleg, other embodiments might be flexible and would not need to be moldedwith a curve. A cover plate (or protective shell) 212 is attached to thebase 202 (FIG. 2B) creating a housing for the tube loop 204 which allowsfor the changing of length, while keeping the tube loop 204 and theincoming tube 206 parallel to the body.

FIG. 3A shows the first embodiment 200 with a safe predetermined forceof 3 ounces acting on the tension spring 210. The resulting position ofthe tube loop 204 is in line with pre-marked calibration markings 302.The line of force 304 caused by the tension spring 210, is in line withthe direction 306 of the Foley catheter. FIG. 3B shows the firstembodiment 200 with a force greater than 3 ounces acting on the tensionspring 210, causing the tension spring 210 to lengthen and allowing agreater length of tube loop 204 to be delivered.

Operation First Embodiment

The catheter controller 200, is attached to the patients leg by means ofan adhesive surface 216 on the backside of the base 202 (FIG. 2B). It isorientated such that the end of the drainage (or outgoing) tube 208points in the general direction of the drainage bag, where it will thenbe connected. As can be seen by FIG. 2A, the outgoing tube 208 isattached to the base 202 and positioned approximately 45° relative tothe bottom edge 215 of the base 202. The 45° angle of the outgoing tube208 optimally places the outgoing tube 208 such that the maximum amountof bend the outgoing tube 208 will have to undergo is about 45°regardless of the patient's leg position. The incoming tube 206 isconnected to the external end of the Foley catheter 100 and is held inconstant tension by the tension spring 210, when placed in between thecalibration markings 302 shown in FIG. 3A (see method of operation forsecuring controller below). Shown in FIGS. 3A and 3B, the line oftension 304 of the tension spring 210, is always parallel with the path306 of the incoming tube 206 and therefore the Foley catheter 100itself. The tension spring 210 effectively pulls on the catheter 100,with a safe, predetermined force of less than 3 ounces (this force hasbeen calculated to be safe, but is subject to change upon furthertesting). This calculated force, is distributed over the contact surfacebetween the balloon and the bottom of the bladder, resulting in asurface pressure that will be less than the blood pressure in the bloodvessels around the base of the bladder. This predetermined force isstrong enough to keep the Foley catheter 100 secure, but not largeenough to damage the blood vessels on the bottom of the bladder. Bypreventing the Foley catheter 100 from moving within the bladder,catheter pistoning is greatly reduced leading to a reduction in patientdiscomfort as well as lowering the risk of infection. A set of markedcalibration lines (or markings) 302 is provided such that the tube canbe moved within these lines and the correct amount of tension will beset. This point is where the tension is at its minimum and the distancefrom the leg attachment point to the catheter is at its minimum. When aforce greater than said safe, predetermined force of the tension spring210, is experienced, such as when the patient's leg is stretched, thetension spring 210 lets out and more drainage tube length is allotted(shown in FIG. 3B). This prevents any force greater than the safepredetermined maximum force, from pulling on the Foley catheter 100 andpotentially causing damage to the bladder 104. This configurationconstantly keeps a safe tension on the Foley catheter 100 while givingor taking excess lengths of the incoming tube 206 to account fordifferent leg and body movement. The cover 212 creates an enclosedhousing for the tube loop 204 which allows for the changing of length,while keeping the tube loop 204 parallel to the body. The cover 212prevents the tube loop 204 and the tension spring 210 from gettingcaught on anything, and also creates a desirable low profile for theuser, especially when worn underneath clothing.

The method of operation for securing the controller, when the controlleris used for catheter tension control, is as follows:

1. Pull lightly on the catheter till the catheter balloon is resting onbladder bottom.

2. Cut incoming tube 206 so that when the catheter connector (notshown), is actually attached to the tube, and when the connector is thenconnected to the catheter, which is now in its most downward positionwith the balloon resting on the bladder bottom, the controller will bein a position about ½ to 1 Inch short of the final desired position onthe thigh.

3. Slide controller along the thigh until the incoming tubing 206 ortension spring 210 is at the calibration lines 302 and the controller ispositioned so that the elastic spring 210, the incoming tube 206 and thecatheter are all in a straight line.

4. Remove backing paper and adhere controller 200 to the thigh.

Other Embodiments

FIGS. 4A and 4B show another embodiment herein called the secondembodiment 400. Instead of a cover plate 212, a cover strap 402 isattached to the base 202 and folds over the tube loop 204, and attachesto the patient's leg, or alternatively, to the bottom section of thebase 220, using an adhesive placed on one end 404. FIG. 4A shows thesecond embodiment 400 in the open position and FIG. 4B shows the secondembodiment 400 in the closed position.

FIG. 5 shows another embodiment herein called the third embodiment 500.In this embodiment 500, the base 502 and cover 504 are molded as onepiece, joined by a living hinge section 506. The living hinge 506 allowsfor the cover 504 to fold over and connect to the base 502 through asnap fitting 510A (male) and 510B (female). The drainage tubecompartment 218 shown in FIG. 2B is replicated in this embodiment 500 bymolded walls 508. A predetermined hole pattern 512 is molded into thebottom surface of the base 502. This hole pattern 512 allows the skin tobreath while the controller is attached, and serves as an adhesiverelease aid as adhesive solvent can be applied through the holes 512 andonto the skin.

Another embodiment may include a means for adjusting the tension of thetension spring 210. This can be accomplished by a number of methods. Onesuch method uses a rotatable dial 600 shown in FIG. 6, a spring loadedslide 700 shown in FIG. 7, and a modified base 800 shown in FIG. 8. Asshown in FIG. 6, the dial 600 has a recess for a mounting post 602, anattachment point 604 for the tension spring 210, a recess 606 for theslide 700, when the tension spring 210 is at the lower tension setting,and a recess 608 for the slide 700, when the tension spring 210 is atthe higher tension setting. Ideally, the lower tension setting providesjust enough tension to keep the tube loop within the device.

The higher tension setting is used when the device is employed tomaintain a constant minimum tension on the catheter. In the latter case,there is the possibility for the doctor or the patient to remove theconstant tension on the catheter if the constant tension creates aproblem. A dial handle 610 is also provided to aid in the rotation ofthe dial 600. Shown in FIG. 7, the slide contains a molded compressionspring section 702, (shown compressed as 702A), a front section 704which fits into the recesses 606, and 608, of the dial 600, and a slidehandle 706 to aid in the movement of the slide 700.

Shown in FIG. 8, the base 800, contains a mounting post 802 for the dial600, a dial compartment 804, a slide compartment 806, and a rib 808 forpreventing the tube loop 204 from contacting the tension spring 210, andas an aid in reducing any possibility of kinking. FIGS. 9A-11B, show thecompleted assembly of the adjustable embodiment 900. FIG. 9A shows thisembodiment 900 in the low tension position. The tension spring 210,attaches to the surface 604 of the dial 600. The dial 600 is placed inthe dial recess 804 of the base 800 such that the mounting post 802 fitsinto the mounting post recess 602. The slide 700, sits in the slidecompartment 806, of the base 800. In the lower tensioned position, thefront section 704 of the slide 700 rests against recess 606 of the dial600 and prevents any clockwise rotation of the dial 600. In thisposition (FIG. 9A), the compression spring 702A of the slide 700, iscompressed. The attachment point 604 of the tension spring 210 to thedial 600 is in the vertical position, meaning no tension is beingapplied. FIG. 9B shows a cross-section view of the adjustable embodiment900 in the un-tensioned position. FIG. 10A shows the adjustableembodiment 900 in the tensioned position. The dial 600 has been rotated90° counter clockwise, causing the tension spring 210 to elongate andthus be in the higher tension mode. With the dial 600, rotated into thisposition, the slide 700 is pushed forward by the slide's compressionspring 702, and rests in the tensioned recess 608 of the dial 600. Thefront section 704 of the slide 700 prevents any further rotation of thedial 600. FIG. 10B shows a cross-section view of the adjustableembodiment 900 in the tensioned position. FIGS. 11A and 11B showcross-sections of the adjustable embodiment 900 with a cover 902 in theclosed position. FIG. 11A shows the embodiment 900 in the lowertensioned position, while FIG. 11B shows the embodiment 900 in thehigher tensioned position. A recess 904 in the cover 902 allows for thedial handle 610 to protrude through when the cover 902 is closed. Asimilar recess 906 is provided for the slide handle 706. Thisconfiguration, allows the user to adjust the tension of the tensionspring 210 without having to open the cover. By pushing the slide 700 tothe right using the slide handle 706, the dial 600 is now able to berotated using the dial handle 610 and tension can either be applied oralleviated.

An example of yet another embodiment is shown in FIG. 12. This deviceprovides a means of adjustment to finely control the degree of forceproduced by the tubing before the tube lengthens or contracts as aresult of leg movements. Container 1210 provides protection for theexpandable tubing (or elastic member) 1228 and provides a place ofattachment to the thigh. The attachment may be direct by means of anadhesive. The container would also prevent the flexible area frombending and collapsing on itself thereby restricting flow to thecollection bag.

Providing a pivoting means for the container, preferably lockable, thatallows the container to pivot in order to reduce the binding friction onthe tubing when the pull is other than in a straight up or downdirection. The pivot may be ball shaped to give a degree of movement inall directions. This type of lockable pivot is commercially available.

Container 1210 is a hollow tube, with a tube bottom 1212, that has ahole 1214 thru which outgoing tube 1222, located at the lower end ofelastic member 1228 passes through and is attached to container 1210 atthe hole 1214.

Elastic member 1228 is shown with a bellows type section that providesthe expansion in this case. The incoming tube 1226 passes freely thru ahole in cap 1230. Cap 1230 has a threaded section 1242 running down mostof its interior length that engages with the threaded section at the topof container 1210.

Spring 1240, which has a smooth finishing coil at both ends that catchunder projections on the expansion unit and projection on the cap unit.

Other embodiments may be used as a method for controlling any othertubing system where expansion and contraction are of concern. By forminga loop, attaching an elastic means across the base of the loop,attaching one end of the elastic loop with the tube attached to thesecurement point desired, and covering the loop with a sheet ofmaterial, the tubing system is constantly in tension, and is keptparallel to the body part, but not close enough to inhibit movement ofthe tube as the loop expands and contracts. This covering can beanything from a fabric loosely spread over the loop and taped to thebody to a sheet of material mounted in such a way as to be parallel tothe body but spaced a distance away that does not inhibit the tubingmovement as it expands and contracts.

It should be noted, that the bellows section of the expansion unit couldbe replaced with a section of coiled tubing instead. In this caseprovision would be made for a projection at a point onto just above thecoiled section on the upper tube onto which the spring could grasp.

The ideal arrangement would have the outer tube adjusted to a heightthat provides enough springiness to just support the tubing above oraround it so that any movement, in any direction can be absorbed by theunit and not transmitted to the catheter. The best arrangement woulddepend on the materials employed and the exact configuration. The mostlikely configuration would involve the accordion or accordion threadconfiguration as the outside tube since it would yield the beststability with the greatest flexibility. It should be noted that acoiled tube within the container could provide this type of flexibility,but would be more difficult to control with a spring in an adjustablemanner.

There is also the possible advantage that an accordion shapedcompensatory section would help in the retardation of bacterial filmgrowth within the tubing because of intermittent flow and the resultingflush action. Compare this to a smooth inner wall and a small continuousflow and the possible increased rate of bacterial film growth when givena continuous path.

Another embodiment is described in U.S. provisional patent applicationNo. 61/478,566 filed Apr. 25, 2011

There are many situations where a continuous tubal path for a liquid orgas is required, such as urinary catheter drainage, IV catheter fluidinsertion, etc. In many of these cases a method that would compensatefor changes in the tube path length and/or some form of tensioningcontrol would be a very desirable feature. In some medical applicationsit could be life-saving. Ideally, the tube should be continuous with asmooth interior fluid path and provide a high degree of extension with alow tensile force. The overall profile should be low with a minimum ofprojections to reduce chance of entanglement as well as to ensurecomfort for the patient. It must be robust enough so that fluid flowwill not stop if pressure exerted on outside of tube.

Embodiment with Thin Wall Stretchable Tube

The embodiments described in FIGS. 13A-15 describe a continuousstretchable tubal path that has a high degree of extension at very lowtensile forces by means of utilizing the elasticity of a very thin wall,easily collapsible elastomer or rubber like tube as part of the tubalpath. It is accomplished by providing means to do the following:

a. Protecting the thin wall section from outside pressures

b. Never allowing the elastomer tube to become shorter in length thanits natural length when under no tension

c. Never allowing the elastomer tube from stretching beyond its breakinglength

d. Never allowing the elastomer tube from twisting

An example of the practical use for such a device would be as a part ofa urinary catheter security device such as the one described in U.S.provisional patent application No. 61/359,912. One need only to add ameans of securing such a device to the thigh and the fittings necessaryto attach the tubing to the urinary catheter on the one end and the tubeleading to the collection bag on the other in order to get theconditions necessary to stabilize a urinary catheter. This arrangementwould have many advantages over the methods described in provisionalpatent application No. 61/359,912.

A further application would be to incorporate such an arrangement asapplied to an IV catheter between the catheter and the medical tubefeeding the IV. In such a case, the IV catheter would be fastened downafter insertion and the tubing fastened down at a point in line with thecatheter, with or without a slight degree of tension on the IV site. Theapplication of a tension factor would reduce the degree of skin movementresulting in less needle movement within the vein. The stretch componentwould reduce the strain on the IV catheter if the medical tube or thesecondary attachment point of the tube were disturbed. This action wouldisolate the tube movement from the catheter thereby reducing the chanceof the catheter either being dislodged or causing damage to the vein orbladder or most any body part a catheter may be employed.

The remaining figures provide possible ways to satisfy the aboveidentified conditions. The incoming tube 1312 is glued to elastic tube(or elastic member) 1314 on one side. The other side of the elastic tubeis glued to exiting (or outgoing) tube 1313, which passes through outershell exiting end hole. The incoming tube 1312 is glued to hole inslider 1316, and is free to slide thru exiting hole 1324. The incomingtube 1312 is free to slide thru outer shell incoming cover end 1319.Slider 1316 slides freely within outer shell 1310. The “D” shape ofslider 1316, within the D shape of outer shell 1310 will prevent anytwisting of elastic tube 1314. Outer shell incoming end 1319 preventsslider 1316 from any further outward movement thereby protecting elastictube 1314 from over stretching. Maximum slider stop projection 1322prevents slider 1316 from moving any closer to outer shell exiting end1311, thereby insuring the minimum length condition needed to maintainelastic tube 1314 shape.

This arrangement has the outer tube protecting the elastic tube fromoutside pressures as well as providing an environment where the elastictube cannot be collapsed by shortening to below its natural length,stretched to its breaking point or twisted out of shape. The result isan elastic tube that is always open to provide a clear path for anyfluid to pass through.

Shows an extension or telescoping tube variation. With this arrangement,the elastic tube (or elastic member) 1414 could be longer if desiredwithout increasing the size of the device. This longer elastic tube willgive a greater extension with a softer pull. This, together with thetelescoping action, will result in less stress on the bladder as well ason the elastic tube in a device that is shorter and easier to manage.The actual stretch could equal the length of the elastic tube, which isabout equal to the outer tube 1410 length. Another feature uses the pin1450 through hole 1418 to keep slider 1416 from moving toward theincoming end. Removing pin 1450 and freeing slider 1416 to move to stop1442, will remove the initial constant tension component. This allowsfor adjustment and/or safe removal of tension during actual use by thenursing staff or by the patient.

FIG. 14A shows an exploded view of a controller that has provision foradjusting or removing the tension on elastic tube 1414 as well as atelescoping shell arrangement that allows for greater stretch in ashorter device.

Outgoing tube 1413 is glued to slider 1416 and then to elastic tube1414, which is glued to incoming tube 1412. Tube 1412 is glued to innershell incoming hole 1444 (as shown in FIG. 14C) in inner shell backplate 1442 is glued to the incoming end of inner shell 1440.

FIG. 14B shows the same exploded view as 14A, but from an opposing view.

FIG. 14C shows a cross-section of the controller fully assembled.Exiting (or outgoing) tube 1413 slides freely in exiting hole 1424.Initially slider 1416 is restrained from moving within outer shell 1410by safety pin 1450. Pin 1450 is held in place by raised projections1452. These projections on safety pin 1450 are not high enough toprevent the pin-1450 from being removed from the entry holes on bothsides of outer shell 1410 with a little additional force. The removal ofthe pin would allow slider 1416 to move over to secondary position 1449,shown as a dotted outline in FIG. 14C, and is stopped from moving anyfurther be slider stop 1432, which is located on the outer shell bottomplate or base 1430. This movement is enough to remove the minimumtension employed when the device is used to maintain a minimal tensionas described in U.S. provisional patent application No. 61/359,912. Whenused in this position, safety pin 1450 could be reinserted to preventthe slider from moving back toward the exiting end. To prevent theelastic tubing from stretching to its breaking point as well as toprevent the inner shell from exiting out of the outer shell, inner shellmaximum movement stop 1446 acts against inner shell stop 1434. Innershell back plate 1442 is fastened to the incoming end of inner shell1440. The inner shell leading edge-1448 against slider 1416 acts as thelimiting condition for maintaining a minimum length of elastic tube1414.

The elastic tube 1414 was dip molded out of a two part elastomer made by“Smooth-on” named Dragon Skin Q. In this case the tube was plain, but itwould be possible to provide special benefits if lateral and/orlongitudinal ribs were molded in at the same time. The tube can be madeof any suitable rubber like product.

In one special variation of the device, the benefits of the flexible,stretchable feature can be applied to an IV device, as shown in FIGS.15A and 15B. In this case, the inner shell 1554 is shaped as shown toallow for more lateral movement of the incoming tube 1512 and betterisolation of any incoming tube disturbance from affecting the IV needleposition within the vein. In this case, the elastic tube 1514 wouldbenefit if it had some small ribs for the short distance at the bendingend. Since the rest of the tube would be of the same cross section, nearmaximum stretch would still be possible. The tension aspect of thedevice could cause a contraction of the skin between the IV site and thesecondary tube attachment site. This contraction causes a significantreduction in skin movement at the IV site, and therefore results in lessneedle movement within the vein. The secondary tube attachment sitecould be a device such as the “Site-saver,” or any other method ofsecuring the incoming tube at a point before it reaches the IV site. Thesecondary site is often used to reduce the strain resulting from outsidetubal movement from affecting the IV needle site. As an added benefit,the flat underside of the IV outer shell 1552 enables the needle to bein a more parallel position relative to the skin, and therefore lesslikely to pierce the vein if disturbed. The larger area of the flatsurface also lends itself to a more secure attachment zone, especiallyif a Velcro solution were to be employed.

FIG. 15A shows an exploded view of an IV model that is yet anotherapplication of the same concept. In this case inner shell 1554 is shapedto allow much greater lateral movement. Outer shell 1552 fastened to IVneedle/catheter 1556 and IV needle/catheter 1556 is attached to elastictube 1514, which is attached to the medical tubing 1512. The other endof elastic tube 1514 is attached to incoming tube 1512 as well as innershell 1554. Inner shell flare is designed to spread contact points ofinner shell 1554 against elastic tube 1514 when in extreme lateralpositions of the incoming tube.

FIG. 15B shows a cross-section of IV model.

Those of skill in the art will recognize certain modifications,permutations, additions and sub-combinations thereof of parts notedherein. While a device or an accompanying method have been described forwhat are presently considered the exemplary embodiments, the inventionis not so limited. To the contrary, the invention is intended to covervarious modifications and equivalent arrangements included within thespirit and scope of the appended claims. The scope of the followingclaims is to be accorded the broadest interpretation so as to encompassall such modifications and equivalent structures and functions.

This arrangement has the outer tube protecting the elastic tube fromoutside pressures as well providing an environment where the elastictube cannot be collapsed by shortening to below its natural length,stretched to its breaking point or twisted out of shape. The result isan elastic tube that is always open to provide a clear path for anyfluid to pass through.

I claim:
 1. A method of minimizing the damage to bodily tissues causedby the movements and pressures of a catheter in a mobile patient'sbladder over several days, the method comprising: inserting the catheterinto the patient's bladder and inflating a balloon against an interiorof the mobile patient's bladder, connecting the catheter to one end of atube, the tube attached to a base; securing the base to a patient'sthigh when a position of the patient's thigh is such that a distancefrom a point of securing to the catheter is at a minimum and the balloonis at a bottom of the bladder, an elastic member elongating andcontracting in response to changes in the relative distance between thebase and the catheter that result from the movements of the mobilepatient whereby the elastic member applies a tensile force not exceedinga safe maximum tensile force to the catheter; conveying the fluid to orfrom the patient's body through the catheter and the tube; whereincreating a condition whereby the elastic member reduces the movement ofthe catheter by compensating for movement of the base by elongating andshortening thus reducing pistonning of the catheter, minimizing damageto bodily tissues and reducing the risk of infection, the elastic membermaintains the direction of pull substantially constant and substantiallymaintaining the tensile force not exceeding the safe maximum tensileforce on the catheter, and the base being attached to the patient'sthigh isolates the catheter from any pulls on an outgoing portion of thetube; wherein the safe maximum tensile force distributed by the balloonover the bottom of the bladder corresponds to a surface pressure that isless than the blood pressure in blood vessels around the bottom of thebladder.
 2. The method of claim 1, wherein the elastic member comprisesa thin wall tube, the method further comprising protecting the thin walltube during use from at least one of: being crushed, snagging on clothesworn by the patient, twisting, stretching beyond a breaking length, andcollapsing upon itself.
 3. The method of claim 2, wherein the controlleris configured to allow for the removal of the applied tensile forcewithout disturbing the catheter.
 4. The method of claim 1, furthercomprising providing a low profile cover or shell to be placed over thebase for protection of the tube and the elastic member, therebyeliminating the chance of crushing or snagging the tube or the elasticmember, and thereby reducing the possibility of large changes of tensileforce on the catheter and/or the stoppage of flow through the tube andthe catheter.
 5. The method of claim 1, further comprising providing anarrangement wherein the elastic member is arranged to act as acompensating device and tension controller and configured to allowmanual adjustments of the applied tensile force while the catheter is inuse by the patient, without moving the base relative to the patient'sthigh.
 6. The method of claim 1, wherein the elastic member includes aspring that is arranged to provide the tension on the tube.
 7. Themethod of claim 1, wherein the elastic member is an elastic portion ofthe tube.
 8. The method of claim 7, wherein the tube includes a firsttube and the elastic portion connected in series where the elasticportion includes a thin wall tube of a different material used for thefirst tube.
 9. The method of claim 8, wherein the elastic portionincludes a dip molded thin walled section.
 10. The method of claim 9,wherein the elastic member is an elastomer.
 11. The method of claim 1,wherein a predetermined force is selected to hold the balloon on thebottom of the patient's bladder without causing damage to blood vesselsor tissues at the bottom of the patient's bladder when the predeterminedforce is applied continuously.
 12. The method of claim 1, wherein thepoint of securement on the body is determined by a method comprising:sliding the base along the thigh away from and in line with the catheteruntil a desired calibration line on at least one of the tube and theelastic member is reached; and securing the base to the thigh.
 13. Themethod according to claim 1, wherein a predetermined force of theballoon against the interior of the patient's bladder is less than about3 ounces thereby allowing for continuous use of the catheter by thepatient.
 14. The method of claim 1, wherein creating a condition wherebythe elastic member further reduces the movement of the catheter bymaintaining a constant tension on the catheter while compensating formovement of the base by elongating and shortening.
 15. A method forminimizing the damage to surrounding body tissues caused by movementsand pressures of a catheter in a patient's bladder over a period ofseveral days where the patient is free to move about and to lower therisk of infection, the method comprising: inserting the catheter intothe patient's bladder and inflating a balloon inside the patient'sbladder; connecting the catheter to a controller having an incoming tubefor connection to the catheter and an outgoing tube for connection to acollection bag, where the incoming tube includes an elastic member thatelongates and/or contracts as the controller moves relative to thecatheter; securing the controller to a thigh of the patient where adistance between the catheter and the controller is at a minimum and theballoon is resting on a bottom of the bladder to provide for a minimaltension on the catheter; conveying fluid from the patient's bladderthrough the catheter and the controller to the collection bag; andcompensating for movement of the controller on the thigh relative to thecatheter by allowing the elastic member to elongate and/or contractwhile maintaining the balloon at the bottom of the bladder andsubstantially applying a tension level on the catheter to minimizepistonning of the catheter, wherein the tension level is limited to notexceed a safe maximum tensile force, the safe maximum tensile forcedistributed by the balloon over the bottom of the bladder correspondingto a surface pressure that is less than the blood pressure in bloodvessels around the bottom of the bladder.
 16. The method according toclaim 15, further comprising selecting a point of securement on thepatient's thigh where the balloon of the catheter rests against thebottom of the bladder to establish the minimal tension on the catheter.17. The method according to claim 15, wherein a predetermined force ofthe balloon against the interior of the patient's bladder is less thanabout 3 ounces thereby allowing for continuous use of the catheter bythe patient over extended periods.
 18. The method according to claim 15,wherein the controller includes a low profile cover over the basecontroller of the incoming tube, the method further including protectingthe elastic member with the cover during use from at least one of beingcrushed, snagging on clothes worn by the patient, twisting, stretchingbeyond its breaking length, and collapsing upon itself.
 19. The methodaccording to claim 15, wherein the controller includes an outer shellover at least said elastic member within a cavity defined by the outershell and the base, a pin capable of insertion through a pair of alignedopenings in the outer shell, and a slider attached to the incoming tube;and the method further including removing the pin from the controller toallow the slider to move within the cavity and additional elongation ofthe elastic material, and re-inserting the pin to limit movement of theslider to set a level of tension applied by the controller on thecatheter leading to adjustment of the tension on the catheter.
 20. Themethod according to claim 15, wherein the incoming tube includes a firstpart and a second part where the second part includes the elastic memberas a thin wall tube having a different material than the first part. 21.The method according to claim 15, wherein the tension level is selectedto hold the balloon at the bottom of the bladder.